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This study is to investigate whether novel soft contact lens optical designs can slow myopia progression
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Lens A | Experimental | Test lenses will be worn in a daily wear modality |
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| Test Lens C | Experimental | Test lenses will be worn in a daily wear modality |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soft Contact Test Lens A | Device | FDA-approved, non-marketed daily disposable soft contact lens, conventional design |
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| Measure | Description | Time Frame |
|---|---|---|
| Spherical Equivalent Refractive Error | Cycloplegic spherical equivalent auto refraction of the subject's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measures, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values in spherical refraction indicate progression in Myopia. | Baseline and every 6 months post-baseline for 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Axial Length | Axial length was measured with the IOLMaster at baseline and every 6 months for 2 years. Five measurements were collected for each visit from the subject's right eye and the average of the five measurements was used for the analysis. | Baseline and every 6 months for 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36809645 | Derived | Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2. | |
| 30994197 | Derived |
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Of those 174 screened subjects, 42 were ineligible to participate in the study and 5 eligible subjects did not randomize to the study arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Lens A | Test lenses will be worn in a daily wear modality |
| FG001 | Test Lens C | Test lens will be worn in a daily wear modality |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline summary was conducted on all subjects who randomized in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Lens A | Test lenses will be worn in a daily wear modality |
| BG001 | Test Lens C | Test lens will be worn in a daily wear modality |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Spherical Equivalent Refractive Error | Cycloplegic spherical equivalent auto refraction of the subject's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measures, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values in spherical refraction indicate progression in Myopia. | Analysis was conducted on all randomized subjects who have at least one data point. | Posted | Mean | Standard Error | diopter (D) | Baseline and every 6 months post-baseline for 2 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects | All subjects who eligible to participate in the study whether or not randomized to the study arm. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| XU CHENG, PRINCIPAL CLINICAL SCIENTIST | Vistakon, USA | 1 904 443-1245 | xcheng6@its.jnj.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Soft Contact Test Lens C | Device | Daily disposable soft contact lens with new optical design |
|
| Cheng X, Xu J, Brennan NA. Accommodation and its role in myopia progression and control with soft contact lenses. Ophthalmic Physiol Opt. 2019 May;39(3):162-171. doi: 10.1111/opo.12614. |
| Lens handling difficulty |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Lost to Follow-up |
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| Subject was fit for ortho - k |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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Test lenses will be worn in a daily wear modality
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| Secondary | Axial Length | Axial length was measured with the IOLMaster at baseline and every 6 months for 2 years. Five measurements were collected for each visit from the subject's right eye and the average of the five measurements was used for the analysis. | Analysis was conducted on all randomized subjects who have at least one data point. | Posted | Mean | Standard Deviation | millimeter (mm) | Baseline and every 6 months for 2 years |
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| 0 |
| 132 |
| 0 |
| 132 |
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| Change from baseline 12 months |
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| Change from baseline 18 months |
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| Change from baseline 24 months |
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